AllergyPhase 2NCT01734265
Safety Clinical Trial With Depigopid 50% Grasses/50% Olea Europaea(2000DPP/ml) or Depigoid 50% Grasses/50% Parietaria Judaica(2000DPP/ml).
A Phase 2 study testing Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml) and Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml) in people with Allergy and Rhinitis, run by Laboratorios Leti, S.L. at 4 sites in Spain.
Trial summary
The primary objective of this study is to evaluate the safety and tolerance of a rush build up administration of Depigoid forte pollen and the first maintenance dose administered 4 weeks later. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergy, Rhinitis, Rhinoconjunctivitis
- What is being tested?
- Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml) and Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 4 sitesSpain
- Study dates
- Nov 2012to Apr 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject has dated and signed the informed consent.
- Men and women between 18 and 60 years of age (both inclusive).
- Individuals suffering symptoms of allergic rhinoconjunctivitis or rhinitis during at least the preceding year, with or without allergic seasonal asthma caused by a clinically relevant sensitization to pollens (grasses AND P. judaica or O. europaea). Asthmatic patients can be included in the trial only if seasonal asthma is controlled with a medium daily dose minor or equal to 800 μg/day of budesonide or an equivalent or minor or equal to 400 μg/day of budesonide or an equivalent plus a long-acting- β2 agonist.
- Asthmatic patients must be stable within 3 months prior to Visit 1 and on an stable inhaled steroid dose within 6 weeks prior to visit 1 and throughout the study. FEV1 must be ≥ 80% of predicted value.
- The IgE-mediated sensitization must be demonstrated by the following:
- medical history AND IgE specific CAP RAST ≥ 2 to the suspected relevant pollens (grass pollen AND Olea and/or Parietaria) AND a positive skin prick test to grass and Olea and/or Parietaria.
Who cannot join
- Any contraindication for treatment with allergen specific immunotherapy.
- Forced expiratory volume in 1 s (FEV1) or peak expiratory flow (PEF) value <80% of the predicted normal value.
- Clinically relevant allergy symptoms due to sensitization to perennial allergens (mites, molds, epithelia) or other seasonal pollen which might interfere with the safety of the IMP.
- Asthma requiring a dose > 800 μg/day of Budesonide or an equivalent, without long-lasting beta-2 agonists or requiring a dose > of 400 μg/day of Budesonide or an equivalent plus a long-acting-β2 agonist to reach asthma control, according to the Global Initiative for Asthma (GINA 2010)
- Patients with non controlled bronchial asthma within 3 months prior to Visit 1.
- Patients with asthma who have been treated with systemic steroids within 3 months prior to V1.
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- Patients with hospital admission due to asthma exacerbations within 1 year prior to V1.
- Acute or chronic inflammatory or infectious diseases of the airways.
- Chronic structural diseases of the respiratory system (for example, emphysema or bronchiectasis).
- Immune system diseases, both autoimmune diseases and immunodeficiency.
- Any disease involving a contraindication for the use of adrenaline (for example, hyperthyroidism).
- Serious uncontrolled diseases involving a risk for the subjects participating in this study
- Malignant disease with activity in the last 5 years.
- Excessive consumption of alcohol, drugs or medication.
- Serious psychiatric, psychological or neurological disorders.
- Systemic or topical treatment with beta-blocker drugs 1 week before visit 2.
- Treatment with substances interfering with the immune system 2 weeks before visit 2.
- Use of tricyclic, tetracyclic and IMAO antidepressants. It will not be allowed to wash up antidepressants to enter the study because of the risks of interrupting antidepressant treatment, so patients on antidepressants therapy cannot be included in the trial.
- Use of systemic corticosteroids 3 months before visit 1.
- Immunization with prophylactic (bacterial or viral) vaccines within 7 days before visit 1 (prophylactic vaccines are allowed during the administration of IMP period provided they are administered at least one week after IMP administration and the next IMP administration is administered at least 14 days later).
- Participation of the subject in another clinical trial 30 days before visit 2
- Subjects who are going to donate stem cells, blood, organs or bone marrow in the course of the study.
- Female subjects who are pregnant or nursing and women with a positive pregnancy test at visit 1 or 2.
- Women of childbearing potential not using highly effective methods of birth control.
- Subjects who are unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
H. Manresa
Manresa, Barcelona, 08243
H. Virgen Macarena
Seville, Sevilla, 41009
H. Virgen del Rocío
Seville, Sevilla, 41013
H. Luis Alcañiz
Xàtiva, Valencia, 46800
About this study
Official title: Prospective, Open Uncontrolled Study to Evaluate the Safety of Depigoid With Two Pollen Combinations (Grasses/Olea and Grasses/Parietaria)2000DPP/ml in Patients With Allergic Rhinitis or Rhinoconjunctivitis With or Without Seasonal Asthma.
The primary objective of this study is to evaluate the safety and tolerance of a rush build up administration of Depigoid forte pollen and the first maintenance dose administered 4 weeks later.
Read the detailed description
The primary objective of this study is to evaluate the safety and tolerance of a rush build up administration of Depigoid forte pollen and the first maintenance dose administered 4 weeks later. The treatment period consists, thus, of 4 weeks.
Primary variable:
•Number of subjects [%] suffering at least one immediate or delayed systemic reaction of grade 2 or higher during the 4-weeks treatment period [grading according to the 2006 EAACI standards
- Conditions
- Allergy, Rhinitis, Rhinoconjunctivitis, Seasonal Asthma
- Being tested
- Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml), Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml)
- Medical subject headings
- Hypersensitivity, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml)Drug
Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml)Drug
| Study group | Role | What they receive |
|---|---|---|
| Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml) | Experimental | Depigoid 50%Grasses/ 50% Olea europaea (2.000 DPP/ml) The administration regimen will consist of a rush build-up regimen: 0.2 ml followed by 0.3 ml after 30 minutes if no adverse events occur a second maintenance dose of 0,5 ml 4 weeks later. Receives: Drug: Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml) |
| Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml) | Experimental | Depigoid 50%Grasses/ 50% Parietaria judaica(2.000 DPP/ml) The administration regimen will consist of a rush build-up regimen: 0.2 ml followed by 0.3 ml after 30 minutes if no adverse events occur a second maintenance dose of 0,5 ml 4 weeks later. Receives: Drug: Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
immediate or delayed systemic reaction of grade 2 or higher during the treatment period
The primary variable in this study is the number of subjects [%] who experienced at least one immediate or delayed systemic reaction of grade 2 or higher during the treatment period.
Measured: 4 weeks
Secondary outcomes (1)
immediate and/or delayed systemic reactions and immediate and/or delayed local reactions
Number of subjects [%] suffering immediate and/or delayed systemic reactions broken down by grade (EAACI classification).
- Number of subjects [%] suffering immediate and/or delayed local reactions broken down by diameter (< 5 cm, 5-10 cm or > 10 cm).
- Number of immediate and/or delayed systemic reactions broken down by grade (EAACI classification).
- Number of immediate and/or delayed local reactions broken down by diameter (< 5 cm, 5-10 cm and > 10 cm).
- (Immunology assessment):Measurement of the following immunological parameters: sIgE and sIgG4 at baseline and at the end of the study (after two maintenance doses).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Leti, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Guardia, Dr, Principal investigator, H. Virgen MacarenaJoaquín Quiralte, Dr, Principal investigator, H. Virgen del RocíoLuis Angel Navarro, Dr, Principal investigator, H. Luis AlcañizSantiago Nevot, Dr, Principal investigator, H. Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734265
- Sponsor's protocol ID
- 6078-PG-PSC-193
- Other IDs
- 2012-001699-12
- Status last verified
- Nov 2012
- First submitted
- 22 Nov 2012
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open Uncontrolled Study to Evaluate the Safety of Depigoid With Two Pollen Combinations (Grasses/Olea and Grasses/Parietaria)2000DPP/ml in Patients With Allergic Rhinitis or Rhinoconjunctivitis With or Without Seasonal Asthma.
- ClinicalTrials.gov ID
- NCT01734265
- Acronym / sponsor ID
- 6078-PG-PSC-193
- Conditions
- Allergy, Rhinitis, Rhinoconjunctivitis, Seasonal Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Laboratorios Leti, S.L.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and tolerance of a rush build up administration of Depigoid forte pollen and the first maintenance dose administered 4 weeks later.
Detailed description
The primary objective of this study is to evaluate the safety and tolerance of a rush build up administration of Depigoid forte pollen and the first maintenance dose administered 4 weeks later. The treatment period consists, thus, of 4 weeks.
Primary variable:
•Number of subjects [%] suffering at least one immediate or delayed systemic reaction of grade 2 or higher during the 4-weeks treatment period [grading according to the 2006 EAACI standards
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml) | Experimental | Drug: Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml)Depigoid 50%Grasses/ 50% Olea europaea (2.000 DPP/ml) The administration regimen will consist of a rush build-up regimen: 0.2 ml followed by 0.3 ml after 30 minutes if no adverse events occur a second maintenance dose of 0,5 ml 4 weeks later. |
| Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml) | Experimental | Drug: Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml)Depigoid 50%Grasses/ 50% Parietaria judaica(2.000 DPP/ml) The administration regimen will consist of a rush build-up regimen: 0.2 ml followed by 0.3 ml after 30 minutes if no adverse events occur a second maintenance dose of 0,5 ml 4 weeks later. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject has dated and signed the informed consent.
- Men and women between 18 and 60 years of age (both inclusive).
- Individuals suffering symptoms of allergic rhinoconjunctivitis or rhinitis during at least the preceding year, with or without allergic seasonal asthma caused by a clinically relevant sensitization to pollens (grasses AND P. judaica or O. europaea). Asthmatic patients can be included in the trial only if seasonal asthma is controlled with a medium daily dose minor or equal to 800 μg/day of budesonide or an equivalent or minor or equal to 400 μg/day of budesonide or an equivalent plus a long-acting- β2 agonist.
- Asthmatic patients must be stable within 3 months prior to Visit 1 and on an stable inhaled steroid dose within 6 weeks prior to visit 1 and throughout the study. FEV1 must be ≥ 80% of predicted value.
- The IgE-mediated sensitization must be demonstrated by the following:
Key exclusion criteria (25 listed)
- Any contraindication for treatment with allergen specific immunotherapy.
- Forced expiratory volume in 1 s (FEV1) or peak expiratory flow (PEF) value <80% of the predicted normal value.
- Clinically relevant allergy symptoms due to sensitization to perennial allergens (mites, molds, epithelia) or other seasonal pollen which might interfere with the safety of the IMP.
- Asthma requiring a dose > 800 μg/day of Budesonide or an equivalent, without long-lasting beta-2 agonists or requiring a dose > of 400 μg/day of Budesonide or an equivalent plus a long-acting-β2 agonist to reach asthma control, according to the Global Initiative for Asthma (GINA 2010)
- Patients with non controlled bronchial asthma within 3 months prior to Visit 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml) | Drug | Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml) |
| Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml) | Drug | Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml) |
Primary outcome
immediate or delayed systemic reaction of grade 2 or higher during the treatment period
Time frame: 4 weeks
The primary variable in this study is the number of subjects [%] who experienced at least one immediate or delayed systemic reaction of grade 2 or higher during the treatment period.
1 secondary outcome
immediate and/or delayed systemic reactions and immediate and/or delayed local reactions
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Guardia, Dr principal investigator
H. Virgen Macarena
Joaquín Quiralte, Dr principal investigator
H. Virgen del Rocío
Luis Angel Navarro, Dr principal investigator
H. Luis Alcañiz
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml) and Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml) in people with Allergy and Rhinitis, run by Laboratorios Leti, S.L. at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immediate or delayed systemic reaction of grade 2 or higher during the treatment period (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.